Here’s why Proteomics (ASX:PIQ) shareholders should brace themselves for a big 2025!

Proteomics (ASX:PIQ) is one of the healthcare stocks to watch in CY25, because it has not one, not two, but three diagnostic tests to be commercialised in Australia, the USA and Europe. It has been a long wait to get to this point, but investors can be confident that there is upside to be realised if the company can successfully execute.

Recap of Protemics (ASX:PIQ)

The company is named after the field of science that examines the structure and function of the proteins. The underlying science is that certain diseases may be detected in the blood earlier than existing conventional methods of disease detection – some of which may be highly invasive, or only able to detect disease when the disease is advanced.

If you can detect and subsequently the diseases earlier, you may have a better chance of defeating them.

The company has 3 tests, all of which based on identifying particular ‘biomarkers’ in a patients blood, have been clinically validated, face major commercial opportunities and are being commercialised in CY25:

• • PromarkerD for DKD (Diabetic Kidney Disease),
  • PromarkerEndo for Endometriosis and,
  • PromarkerEso for Esophageal cancer.

PromarkerEndo and PromarkerEso are purely diagnostic tests, while PromarkerD is a predictive test. The company intends to bring PromarkerD to market in Australia in Q1 2024, followed by the EU and USA later in CY25. It intends to launch the other two tests in Australia in mid-CY25 with the EU and USA gradually over the following 2 years.

Source: Company

A big opportunity awaits

PromarkerD has a market opportunity of 21.1m in the USA, 40.9m in the EU and 1m in Australia. These are the two-thirds of diabetics who do not have DKD, as PIQ believes it can serve them by predicting whether or not they will develop DKD.

For PromarkerEndo, it is estimated that one-ninth of women of child-bearing age suffer from endometriosis and this is 7.39m in the USA, 14.8m in the EU and 609k in Australia. PromarkerEso’s aim is to provide an easy testing alternative to endoscopic scans. PIQ estimates there are 390,000 Australians eligible for them, and we believe there are 1.5m in the USA and 2m in the EU.

PIQ will commercialise in the US using the Lab Developed Test (LDT) pathway as an alternative to FDA 510(k) registration. PromarkerD will receive a US$390.75 reimbursement rate from Medicare. In Australia, it will be launched via the equivalent pathway – the ISO 15189 – while PromarkerD has CE Mark approval for Europe.

Proteomics is pursuing a hybrid go-to-market strategy comprising a new Direct to Customer/Patient (DTC/DTP) model alongside the traditional licensing model which had been anticipated by investors whilst the agreement with Sonic USA existed. This may mean Promarker may not reach as high a proportion of the market – at least not as fast – as it would have with a licensing deal, but it will mean the company keeps a higher share of revenue than it otherwise would.

This could also be the tip of the iceberg for Proteomics’ potential. The company has future aspirations to use its underlying science to develop and commercialise tests against other indications including Asthma, Chronic Obstructive Pulmonary Disease (COPD), Plant Dieback, Diabetic Retinopathy and Diabetic neuropathy.

Pitt Street Research sees upside in PIQ

Our friends at Pitt Street Research have published a report on Proteomics this morning, valuing the company at $295.3m in a base case and $446.6m in an optimistic (or bull) case. These figures amount to $2.19 per share and $3.31 per share respectively. This assumes successful commercialisation of Proteomics’ three tests on schedule. We encourage investors curious to find out more to read the report and to check out the company’s presentation to the Stocks Down Under Healthcare and Life Sciences Conference earlier this year.

Proteomics investors have a lot to look forward to in 2025!

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